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EVS-EN ISO 10993-5:2009+A11:2025

Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)

General information

Valid from 02.06.2025
Base Documents
ISO 10993-5:2009; EN ISO 10993-5:2009; EN ISO 10993-5:2009/A11:2025
Directives or regulations
None

Standard history

Status
Date
Type
Name
02.06.2025
Main + amendment
This part of ISO 10993 describes test methods to assess the in vitro cytotoxicity of medical devices.
These methods specify the incubation of cultured cells in contact with a device and/or extracts of a device either directly or through diffusion.
These methods are designed to determine the biological response of mammalian cells in vitro using appropriate biological parameters.

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